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Avodart

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Avodart

Avodart

INDICATIONS

Monotherapy

AVODART® (dutasteride) Soft Gelatin Capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:

  • improve symptoms,
  • reduce the risk of acute urinary retention (AUR), and
  • reduce the risk of the need for BPH-related surgery.

Combination With Alpha Adrenergic Antagonist

AVODART in combination with the alpha adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.

Limitations of Use

AVODART is not approved for the prevention of prostate cancer.

DOSAGE AND ADMINISTRATION

The capsules should be swallowed whole and not chewed or opened, as contact with the capsule contents may result in irritation of the oropharyngeal mucosa. AVODART may be administered with or without food.

Monotherapy

The recommended dose of AVODART is 1 capsule (0.5 mg) taken once daily.

Combination With Alpha Adrenergic Antagonist

The recommended dose of AVODART is 1 capsule (0.5 mg) taken once daily and tamsulosin 0.4 mg taken once daily.

HOW SUPPLIED

Dosage Forms And Strengths

0.5-mg, opaque, dull yellow, gelatin capsules imprinted with “GX CE2” in red ink on one side.

Storage And Handling

AVODART Soft Gelatin Capsules 0.5 mg are oblong, opaque, dull yellow, gelatin capsules imprinted with “GX CE2” with red edible ink on one side, packaged in bottles of 30 (NDC 0173-0712-15) and 90 (NDC 0173-0712-04) with child-resistant closures.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Dutasteride is absorbed through the skin. AVODART Capsules should not be handled by women who are pregnant or who could become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus [see WARNINGS AND PRECAUTIONS].

GlaxoSmithKline Research Triangle Park, NC 27709. Manufactured by Catalent Pharma Solutions Somerset, NJ 08873 for GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: October 2012

Last reviewed on RxList: 5/16/2013
This monograph has been modified to include the generic and brand name in many instances.

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